U.S. Pat. No. 2,512,568 discloses and claims a hypodermic injection device being composed of an organic resinous material, said needle and barrel being integral and having a sharp edge adapted to pierce and penetrate the skin adjacent to the underlying tissue. U.S. Pat. No. 2,512,568 in general describes a polymeric needle, but does not suggest the unique structural configuration of the injection end disclosed herein. The injection end disclosed in U.S. Pat. No. 2,512,568 is the same biased end that is used today in metal needles. U.S. Pat. No. 2,512,568 is herein incorporated by reference.
U.S. Pat. No. 4,369,768 discloses and claims a fiber optics device, or operative arthroscope, wherein a fiber optic channel containing a number of fiber optic strands are secured and retained in place through a sleeve which may be plastic or metal. The flexible sheath encases the entire operative assembly carrying the irrigation channels. There is no suggestion that the polymeric portion of the device could be used to penetrate the skin. In fact, the use of the '768 device requires a surgical procedure prior to entering the body.
U.S. Pat. No. 3,940,802 is concerned with a medical appliance made of plastic, more specifically, polyvinylchloride wherein the polyvinylchloride is made more suitable for us in direct or indirect contact with human blood via the use of a polyurethane as a plasticizer.
U.S. Pat. No. 2,954,768 discloses a puncture point comprising a tubular shaft; an inner surface on said shaft defining a longitudinal passage: a conical point: a frusto-conical shoulder between said shaft and said point: walls defining channels extending longitudinally through said shoulder and along a portion of the shaft. In addition, this patent describes a device that possesses walls that slant inwardly toward the bottom of each channel which meet the inner surface of the shaft thereby defining a slot in each channel opening into the passage and a slanted surface extending rearwardly from each slot to the outer surface of the shaft. The injection or puncture device of U.S. Pat. No. 2,954,768 contains walls defining channels extending longitudinally through a shoulder which are not present in the instant invention.
U.S. Pat. No. 3,090,384 discloses a standard bias cut tube wherein the main bevel of the lancet extends at a 12 degree angle with reference to the needle axis and side bevels extended at 15 degrees with reference to the needle axis. This patent does not suggest a solid conical penetrating point with an included angle of from 10-22 degrees nor does it suggest the exit portals of the instant invention which possess side walls that are cut so as to impart a swirling motion or torque to the injected fluid.
U.S. Pat. No. 3,645,268 is concerned with a self locating and piercing evacuator tube. This ear evacuator possesses a shoulder and cutting edges for incision of the tympanic membrane. The instant invention does not possess cutting edges, nor the shoulders or stop means of the '268 device.
Germany DE No. 3020926 discloses a syringe for lumbar puncture which has a conical closed needle tip with lateral aperture. This reference fails to disclose or suggest portals flush with the exterior of the device which would impart angular momentum to the injected fluid. Further, this German reference contains a singular portal that is ground into the tube which adds additional surfaces to the exterior of the device and thus would not be flush with the exterior of the device. In addition, the referenced device would not spiral or impart an angular momentum to the injected fluid as would the instant invention.
U.S. Pat. No. 4,411,661 discloses a spike connector having a main body portion and a hollowed spike extending therefrom for insertion into the stopper of a fluid source, the improvement comprising a pair of wings extending from the spike. This device designed to drain fluid from a container possesses openings or portals that are not flush with the exterior surface and further if used to inject a fluid would not do so in a swirling motion. In addition, the device possesses a shoulder at the junction of the conical point and the shaft of the tube which is not an aspect of the instant invention.
U.S. Pat. No. 4,413,993 discloses an infiltration proof intravenous needle comprising a round elongated hollow needle shaft tapering to a completely round elongated tip terminating in a sharp point lying on the axis of the needle shaft and an opening of said needle shaft. This patent fails to disclose the essential feature of the instant invention, that being the configuration of the opening or portal which would impart torque or angular momentum to the fluid to be injected. This patent fails to appreciate the beneficial effects that can be realized when the fluid is injected in a swirling motion. That motion or angular momentum is accomplished in this invention through the design of the walls of the opening or portal.
One common shortfall of the presently accepted hypodermic injection devices is that the substance to be injected is done so in a manner parallel with the axis of the needle, and thus, causes additional trauma to the surrounding tissue. Related to this effect, is the trauma to tissue caused by high pressures that are generated by the injection of both the medication and the forcing out of the tissue which was cored when the skin and subcutaneous tissues were passed through. In addition, the high concentration of injected material at the site of penetration is detrimental to muscle tissue. The present invention overcomes these problems through a unique configuration of the injection end that provides for delivery of the substance to be injected multi-directionally and substantially perpendicular to the axis of the device in a swirling motion. Through molding or forming techniques of the portal side walls, the torque or swirling of the fluid being injected can be varied as desired. Such a design allows the injection to take place essentially parallel to the muscle fibers and tissue planes. This permits a more natural separation of tissue and consequently less trauma.
Venipuncture is one of the more commonly performed medical procedures. Such surgical puncture of a vein to either withdraw fluid or insert a needle, to administer intravenous fluid can be a difficult and painful procedure for many patients, especially for children or the frequently hospitalized patients in whom it can be difficult to insert a large bore needle into a vein. The present invention minimizes the discomfort associated with such procedures, and is particularly useful in treating children and patients in whom it is hard to find a moderate size vein. Through the ported conical configuration, smaller bore or gauge needles can be used to accomplish what once required a large bore needle.
When an injection is administered to a patient, the tissue around the injection site undergoes a localized area of necrosis or tissue death. In the conventional bias cut ferrous needle, the cored out tissue that is injected in advance of the injectate must displace the surrounding tissue so as to allow the tissue to expand and create a "pocket" for the medication. This causes the stretching of nerve fibers in the muscle and produces the sensation of pain. The injected medication displaces the surrounding tissue in a manner that is perpendicular to the muscle fibers; thus causing pain.
The site of skin penetration and associated trauma to this area requires time to heal. The conventional ferrous needle with its coring effect requires a longer healing process. A close examination of the wound from a conventional needle will exhibit a cut, similar to the one that is created by a surgical incision. The needle of this invention does not produce an incision but a puncture. The puncture site will heal more quickly than will a cut surface. In addition, the inherent nature of the various polymers utilized in the needle construction will eliminate tissue drag almost entirely. This would cause less "pulling of the tissue" thus less discomfort to the patient.
None of the prior art suggests or discloses the instant device which overcomes the numerous problems presently tolerated in the medical profession.